carbamates and Stroke

carbamates has been researched along with Stroke in 10 studies

Stroke: A group of pathological conditions characterized by sudden, non-convulsive loss of neurological function due to BRAIN ISCHEMIA or INTRACRANIAL HEMORRHAGES. Stroke is classified by the type of tissue NECROSIS, such as the anatomic location, vasculature involved, etiology, age of the affected individual, and hemorrhagic vs. non-hemorrhagic nature. (From Adams et al., Principles of Neurology, 6th ed, pp777-810)

Research

Studies (10)

Authors

Clinical Trials (16)

Trial Overview

Trial Outcomes

Adjusted Change From Baseline in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT at Week 76 + 30 Days

Cortical thickness was measured by QCT. Change was calculated as thickness at Week 76 + 30 days minus thickness at Baseline. (NCT00679939)
Timeframe: Baseline and Week 76 + 30 days

Adjusted Change From Baseline in Femoral Neck (FN) Infero-anterior Cortical vBMD Via QCT at Week 76 + 30 Days

vBMD was measured by QCT. Change from Baseline at Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at baseline and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-anterior is the lower and front section of the FN. (NCT00679939)
Timeframe: Baseline and Week 76 + 30 days

Adjusted Change From Baseline in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT at Week 76 + 30 Days

Cortical thickness was measured by QCT. Change from Baseline was calculated as thickness at Week 76 + 30 days minus thickness at Baseline. (NCT00679939)
Timeframe: Baseline and Week 76 + 30 days

Adjusted Change From Baseline in Femoral Neck (FN) Infero-posterior Cortical vBMD Via QCT at Week 76 + 30 Days

vBMD was measured by QCT. Change from Baseline at Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at baseline and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-posterior is the lower and back section of the FN. (NCT00679939)
Timeframe: Baseline and Week 76 + 30 days

Adjusted Change From Baseline in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT at Week 76 + 30 Days

Cortical thickness was measured by QCT. Change from baseline was calculated as thickness at Week 76 + 30 days minus thickness at Baseline. (NCT00679939)
Timeframe: Baseline and Week 76 + 30 days

Adjusted Change From Baseline in Femoral Neck (FN) Supero-anterior Cortical vBMD Via QCT at Week 76 + 30 Days

vBMD was measured by QCT. Change from Baseline at Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at baseline and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Supero-anterior is the upper and front section of the FN. (NCT00679939)
Timeframe: Baseline and Week 76 + 30 days

Adjusted Change From Baseline in Femoral Neck (FN) Supero-posterior and Cortical vBMD Via QCT at Week 76 + 30 Days

vBMD was measured by QCT. Change from Baseline at Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at baseline and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Supero-posterior is the upper and back section of the FN. (NCT00679939)
Timeframe: Baseline and Week 76 + 30 days

Adjusted Change From Baseline in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT at Week 76 + 30 Days

Cortical thickness was measured by QCT. Change from baseline was calculated as thickness at Week 76 + 30 days minus thickness at Baseline. (NCT00679939)
Timeframe: Baseline and Week 76 + 30 days

Adjusted Change in Albumin-adjusted Serum Calcium (AASC) From Week 52 to Week 76

AASC levels were measured from blood samples. AASC is the amount of free calcium circulating in the blood and calcium is required for good bone health. Change from Week 52 was calculated as the Week 76 value minus the Week 52 value and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region. (NCT00679939)
Timeframe: Week 52 and Week 76

Adjusted Change in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days

Cortical thickness was measured by QCT. Change was calculated as thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

Adjusted Change in Femoral Neck (FN) Infero-anterior Cortical vBMD Via QCT From Week 52 + 30 Days to Week 76 + 30 Days

vBMD was measured by QCT. Change from Week 52 + 30 days to Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-anterior is the lower and front section of the FN. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

Adjusted Change in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days

Cortical thickness was measured by QCT. Change was calculated as thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

Adjusted Change in Femoral Neck (FN) Infero-posterior Cortical vBMD Via QCT From Week 52 + 30 Days to Week 76 + 30 Days

vBMD was measured by QCT. Change from Week 52 + 30 days to Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-posterior is the lower and back section of the FN. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

Adjusted Change in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT From Week 52+30 Days to Week 76 + 30 Days

Cortical thickness was measured by QCT. Change was calculated as thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

Adjusted Change in Femoral Neck (FN) Supero-anterior Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days

vBMD was measured by QCT. Change from Week 52 + 30 days to Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Supero-anterior is the upper and front section of the FN. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

Adjusted Change in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days

Cortical thickness was measured by QCT. Change was calculated as thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

Adjusted Change in Femoral Neck (FN) Supero-posterior Cortical vBMD Via QCT From Week 52 + 30 Days to Week 76 + 30 Days

vBMD was measured by QCT. Change from Week 52 + 30 days to Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therpay, and region. Supero-posterior is the upper and back section of the FN. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

Adjusted Percent Change From Baseline in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) at Week 52

FN BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Bone mineral density is calculated as the mineral content of a bone divided by the area of the bone. DXA is the principal technique used for measuring BMD. Percent change from Baseline at Week 52 was calculated as (BMD at Week 52 minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Change in FN BMD at Week 52 was only analyzed within the Rosiglitazone arm. (NCT00679939)
Timeframe: Baseline and Week 52

Adjusted Percent Change From Baseline in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) at Week 76+10 Days

FN BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Bone mineral density is calculated as the mineral content of a bone divided by the area of the bone. DXA is the principal technique used for measuring BMD. Percent change from Baseline at Week 76+10 days was calculated as (BMD at Week 76+10 days minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. (NCT00679939)
Timeframe: Baseline and Week 76+10 days

Adjusted Percent Change in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) From Week 52 +10 Days to Week 76+10 Days

FN BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Bone mineral density is calculated as the mineral content of a bone divided by the area of the bone. DXA is the principal technique used for measuring BMD. Percent change from Week 52+10 days to Week 76+10 days was calculated as (BMD at Week 76+10 days minus BMD at Week 52+10 days)/BMD at Week 52+10 days x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. (NCT00679939)
Timeframe: Week 52+10 days and Week 76+10 days

Adjusted Percent Change in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days

Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days)/thickness at Week 52 + 30 days x 100%. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

Adjusted Percent Change in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days

Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days)/thickness at Week 52 + 30 days x 100%. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

Adjusted Percent Change in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days

Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days)/thickness at Week 52 + 30 days x 100%. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

Adjusted Percent Change in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT From Week 52+30 Days to Week 76 + 30 Days

Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days)/thickness at Week 52 + 30 days x 100%. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

Adjusted Percent Change in Vertebral Trabecular vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days

BMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

Adjusted Change From Baseline in Albumin-adjusted Serum Calcium (AASC) at Week 52 and Week 76

AASC levels were measured from blood samples. AASC is the amount of free calcium circulating in the blood and calcium is required for good bone health. Change from baseline was calculated as the Week 52or Week 76 value minus the baseline value and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region. (NCT00679939)
Timeframe: Baseline, Week 52, and Week 76

Adjusted Percent Change From Baseline in 25-Hydroxyvitamin D (Vitamin D) at Week 52 and Week 76

Vitamin D levels were measured in nanomoles per Liter (nmol/L) from blood samples. Vitamin D is required for good bone health. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region. (NCT00679939)
Timeframe: Baseline, Week 52, and Week 76

Adjusted Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) at Week 52 and Week 76

BSAP and P1NP levels were measured in micrograms per liter (mcg/L) from blood samples. BSAP and P1NP are indicators of bone buildup or formation. GM, geometric mean; SE, standard error. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region. (NCT00679939)
Timeframe: Baseline, Week 52, and Week 76

Adjusted Percent Change From Baseline in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) at Week 52 and Week 76

CTX levels were measured in picograms per milliliter (pg/ml) from blood samples. CTX is an indicator of bone break down or resorption. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region. (NCT00679939)
Timeframe: Baseline, Week 52, and Week 76

Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days

Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 52 + 30 days (orWeek 76 + 30 days) minus thickness at Baseline)/thickness at Baseline x 100%. (NCT00679939)
Timeframe: Baseline, Week 52 + 30 days, and Week 76 + 30 days

Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days

vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (orWeek 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-anterior is the lower and front section of the FN. (NCT00679939)
Timeframe: Baseline, Week 52 + 30 days, and Week 76 + 30 days

Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days

Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 52 + 30 days (or Week 76 + 30 days) minus thickness at Baseline)/thickness at Baseline x 100%. (NCT00679939)
Timeframe: Baseline, Week 52 + 30 days, and Week 76 + 30 days

Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days

vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (or Week 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-posterior is the lower and back section of the FN. (NCT00679939)
Timeframe: Baseline, Week 52 + 30 days, and Week 76 + 30 days

Adjusted Percent Change From Baseline in Femoral Neck (FN) Integral, FN Trabecular, and FN Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days

vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (orWeek 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. (NCT00679939)
Timeframe: Baseline, Week 52 + 30 days, and Week 76 + 30 days

Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days

Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 52 + 30 days(or Week 76 + 30 days) minus thickness at Baseline)/thickness at Baseline x 100%. (NCT00679939)
Timeframe: Baseline, Week 52 + 30 days, and Week 76 + 30 days

Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days

vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 daysor Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days(or Week 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Supero-anterior is the upper and front section of the FN. (NCT00679939)
Timeframe: Baseline, Week 52 plus 30 days, and Week 76 + 30 days

Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days

Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 52 + 30 days (or Week 76 + 30 days) minus thickness at Baseline)/thickness at Baseline x 100% (NCT00679939)
Timeframe: Baseline, Week 52 + 30 days, and Week 76 + 30 days

Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days

vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days orWeek 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (or Week 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therpay, and region. Supero-posterior is the upper and back section of the FN. (NCT00679939)
Timeframe: Baseline, Week 52 + 30 days, and Week 76 + 30 days

Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) at Week 52 + 30 Days and Week 76 + 30 Days

BMD (measured in grams per centimeters squared [g/cm^2]) was measured by QCT. BMD by QCT is the 2-dimensional volume that mimics the DXA measurement for the same region. Percent change from Baseline at Week 52 + 30 days orWeek 76 + 30 days was calculated as (BMD at Week 52 + 30 days (orWeek 76 + 30 days) minus BMD at baseline)/BMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. (NCT00679939)
Timeframe: Baseline, Week 52 + 30 days, and Week 76 + 30 days

Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52

BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Percent change from Baseline at Week 52 was calculated as (BMD at Week 52 minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. (NCT00679939)
Timeframe: Baseline and Week 52

Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 10 Days and Week 76 + 10 Days

BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Percent change from Baseline at Week 52 + 10 days or Week 76 + 10 days was calculated as (BMD at Week 52 + 10 days (or Week 76 + 10 days ) minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. (NCT00679939)
Timeframe: Baseline, Week 52 + 10 days, and Week 76 + 10 days

Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 30 Days and Week 76 + 30 Days

BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (BMD at Week 52 + 30 days (or Week 76 + 30 days) minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. (NCT00679939)
Timeframe: Baseline, Week 52 + 30 days, and Week 76 + 30 days

Adjusted Percent Change From Baseline in Intact Parathyroid Hormone (PTH) at Week 52 and Week 76

Intact PTH levels were measured in nanograms per Liter (ng/L) from blood samples. Intact PTH is the amount of PTH circulating in the blood and influences bone health. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region. (NCT00679939)
Timeframe: Baseline, Week 52, and Week 76

Adjusted Percent Change From Baseline in Intertrochanter Integral, Intertrochanter Trabecular, and Intertrochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days

vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (or Week 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. (NCT00679939)
Timeframe: Baseline, Week 52 + 30 days, and Week 76 + 30 days

Adjusted Percent Change From Baseline in Total Hip (TH) Integral, TH Trabecular, and TH Cortical vBMD Via QCT at Week 52 + 30 Days and at Week 76 + 30 Days

Volumetric (v)BMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. vBMD is the 3-dimensional density of a region of bone. Cortical bone is dense bone. Trabecular bone is spongy bone. Integral bone is the sum of cortical and trabecular bone measurements. Cortical thickness is the width of the cortical shell. Percent change from Baseline was calculated as (vBMD at Week 52+30 days (or Week 76+30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by ANCOVA with terms for treatment, baseline value, prior therapy, and region. (NCT00679939)
Timeframe: Baseline, Week 52 + 30 days, and Week 76 + 30 days

Adjusted Percent Change From Baseline in Trochanter Integral, Trochanter Trabecular, and Trochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days

vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (or Week 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. (NCT00679939)
Timeframe: Baseline, Week 52 + 30 days, and Week 76 + 30 days

Adjusted Percent Change From Baseline in Vertebral Trabecular vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days

BMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (orWeek 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. (NCT00679939)
Timeframe: Baseline, Week 52 + 30 days, and Week 76 + 30 days

Adjusted Percent Change in 25-Hydroxyvitamin D (Vitamin D) From Week 52 to Week 76

Vitamin D levels were measured in nanomoles per Liter (nmol/L) from blood samples. Vitamin D is required for good bone health. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region. (NCT00679939)
Timeframe: Week 52 and Week 76

Adjusted Percent Change in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) From Week 52 to Week 76

BSAP and P1NP levels were measured in micrograms per liter (mcg/L) from blood samples. BSAP and P1NP are indicators of bone buildup or formation. GM, geometric mean; SE, standard error. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region. (NCT00679939)
Timeframe: Week 52 and Week 76

Adjusted Percent Change in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) From Week 52 to Week 76

CTX levels were measured in picograms per milliliter (pg/ml) from blood samples. CTX is an indicator of bone break down or resorption. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region. (NCT00679939)
Timeframe: Week 52 and Week 76

Adjusted Percent Change in Femoral Neck (FN) Infero-anterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days

vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-anterior is the lower and front section of the FN. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

Adjusted Percent Change in Femoral Neck (FN) Infero-posterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days

vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-posterior is the lower and back section of the FN. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

Adjusted Percent Change in Femoral Neck (FN) Integral, FN Trabecular, and FN Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days

vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

Adjusted Percent Change in Femoral Neck (FN) Supero-anterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days

vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Supero-anterior is the upper and front section of the FN. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

Adjusted Percent Change in Femoral Neck (FN) Supero-posterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days

vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therpay, and region. Supero-posterior is the upper and back section of the FN. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) From Week 52+30 Days to Week 76 + 30 Days

BMD (measured in grams per centimeters squared [g/cm^2]) was measured by QCT. BMD by QCT is the 2-dimensional volume that mimics the DXA measurement for the same region. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (BMD at Week 76 + 30 days minus BMD at Week 52 + 30 days)/BMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA From Week 52+10 Days to Week 76 + 10 Days

BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Percent change from Week 52 + 10 days toat Week 76 + 10 days was calculated as (BMD at Week 76 + 10 days minus BMD at Week 52 + 10 days)/BMD at Week 52 + 10 days x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. (NCT00679939)
Timeframe: Week 52 + 10 days and Week 76 + 10 days

Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA From Week 52+30 Days to Week 76 + 30 Days

BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (BMD at Week 76 + 30 days minus BMD at Week 52 + 30 days)/BMD at Week 52 + 30 days x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

Adjusted Percent Change in Intact Parathyroid Hormone (PTH) From Week 52 to Week 76

Intact PTH levels were measured in nanograms per Liter (ng/L) from blood samples. Intact PTH is the amount of PTH circulating in the blood and influences bone health. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region. (NCT00679939)
Timeframe: Week 52 and Week 76

Adjusted Percent Change in Intertrochanter Integral, Intertrochanter Trabecular, and Intertrochanter Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days

vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

Adjusted Percent Change in Total Hip (TH) Integral, TH Trabecular, and TH Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days

Volumetric (v)BMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. vBMD is the 3-dimensional density of a region of bone. Cortical bone is dense bone. Trabecular bone is spongy bone. Integral bone is the sum of cortical and trabecular bone measurements. Cortical thickness is the width of the cortical shell. Percent change from Week 52 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/ vBMD at Week 52 + 30 days x 100% and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

Adjusted Percent Change in Trochanter Integral, Trochanter Trabecular, and Trochanter Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days

vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. (NCT00679939)
Timeframe: Week 52 + 30 days and Week 76 + 30 days

Percent Change From Baseline in Free Testosterone at Week 52 and Week 76

Free testosterone levels were measured as a percentage of total testosterone from blood samples. Free testosterone is the amount of testosterone available to the body for use. Percent change from baseline was based on log-transformed data. (NCT00679939)
Timeframe: Baseline, Week 52, and Week 76

Percent Change From Baseline in Serum Estradiol at Week 52 and Week 76

Serum estradiol levels were measured in picomoles per Liter (pmol/L) from blood samples. Estradiol is one form of the female sex hormone estrogen and influences bone health. Percent change from baseline was based on log-transformed data. (NCT00679939)
Timeframe: Baseline, Week 52, and Week 76

Percent Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Week 52 and Week 76

SHBG levels were measured in nanomoles per liter (nmol/L) from blood samples. SHBG binds to estradiol and testosterone and influences the amount of estradiol or testosterone available to the body for use. Percent change from baseline was based on log-transformed data. (NCT00679939)
Timeframe: Baseline, Week 52, and Week 76

Percent Change From Baseline in Total Testosterone at Week 52 and Week 76

Total testosterone levels were measured in nanomoles per Liter (nmol/L) from blood samples. Testosterone is a male sex hormone and influences bone health; total testosterone is the entire amount circulating in blood. Percent change from baseline was based on log-transformed data. (NCT00679939)
Timeframe: Baseline, Week 52, and Week 76

Percent Change in Free Estradiol From Week 52 to Week 76

Free estradiol levels were measured in picomoles per Liter (pmol/L) from blood samples. Free estrodial is the amount of estrogen available to the body for use. Change was based on log-transformed data. (NCT00679939)
Timeframe: Week 52 and Week 76

Percent Change in Free Testosterone From Week 52 to Week 76

Free testosterone levels were measured as a percentage of total testosterone from blood samples. Free testosterone is the amount of testosterone available to the body for use. Percent change from baseline was based on log-transformed data. (NCT00679939)
Timeframe: Week 52 and Week 76

Percent Change in Percentage of Free Estradiol From Week 52 to Week 76

Free estradiol levels were measured as a percentage of serum estrogen from blood samples. Free estradiol is the amount of estrogen available to the body for use. Percent change was based on log-transformed data. (NCT00679939)
Timeframe: Week 52 and Week 76

Percent Change in Serum Estradiol From Week 52 to Week 76

Serum estradiol levels were measured in picomoles per Liter (pmol/L) from blood samples. Estradiol is one form of the female sex hormone estrogen and influences bone health. Percent change from baseline was based on log-transformed data. (NCT00679939)
Timeframe: Week 52 and Week 76

Percent Change in Sex Hormone Binding Globulin (SHBG) From Week 52 to Week 76

SHBG levels were measured in nanomoles per liter (nmol/L) from blood samples. SHBG binds to estradiol and testosterone and influences the amount of estradiol or testosterone available to the body for use. Percent change from baseline was based on log-transformed data. (NCT00679939)
Timeframe: Week 52 and Week 76

Percent Change in Total Testosterone From Week 52 to Week 76

Total testosterone levels were measured in nanomoles per Liter (nmol/L) from blood samples. Testosterone is a male sex hormone and influences bone health; total testosterone is the entire amount circulating in blood. Percent change from baseline was based on log-transformed data. (NCT00679939)
Timeframe: Week 52 and Week 76

Differences in Augmentation Index at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R.

Differences in augmentation index (AI, %) using oscillometry at baseline and 3, 6 and 12 months after treatment with metformin or agonist GLP-1R. (NCT03010683)
Timeframe: Baseline, 3 months, 6 months, and 12 months.

Differences in Endothelial Glycocalyx Thickness at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R.

Differences in endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels at baseline and 3, 6 and 12 months after treatment with metformin or agonist GLP-1R. High PBR values represent reduced glycocalyx thickness. (NCT03010683)
Timeframe: Baseline, 3 months, 6 months, and 12 months.

Differences in Pulse Wave Velocity at Baseline and 3, 6 and 12 Months After Treatment With Metformin or Agonist GLP-1R.

Differences in carotid-femoral pulse wave velocity (PWV, m/sec) using tonometry at baseline and 3, 6 and 12 months after treatment with metformin or agonist GLP-1R. (NCT03010683)
Timeframe: Baseline, 3 months, 6 months and 12 months

Endothelial Glycocalyx and Pulse Wave Velocity.

Association of endothelial glycocalyx thickness as assessed by perfused boundary region (PBR, micrometers) of the sublingual arterial microvessels with pulse wave velocity (PWV, m/sec) at baseline and 3, 6 and 12 months after treatment with metformin or agonist GLP-1R. (NCT03010683)
Timeframe: Baseline, 3 months, 6 months, and 12 months.

Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy

Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus metformin versus metformin alone at Week 24. (NCT00327015)
Timeframe: Week 24

Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy

Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus metformin versus saxagliptin alone at Week 24. (NCT00327015)
Timeframe: Week 24

Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy

Percentage of participants achieving A1C ≤6.5%, at each dose of saxagliptin plus metformin versus metformin alone at Week 24. (NCT00327015)
Timeframe: Week 24

Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy

Percentage of participants achieving A1C ≤6.5%, at each dose of saxagliptin plus metformin versus saxagliptin alone at Week 24. (NCT00327015)
Timeframe: Week 24

Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy

Percentage of participants requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24-week treatment period at each dose of saxagliptin plus metformin versus metformin alone. (NCT00327015)
Timeframe: Week 24

Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy

Percentage of participants requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24-week treatment period at each dose of saxagliptin plus metformin versus saxagliptin alone. (NCT00327015)
Timeframe: Week 24

Change From Baseline in A1C at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy

Mean change from baseline in A1C at Week 24, adjusted for baseline value. (NCT00327015)
Timeframe: Baseline, Week 24

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy

Mean change from baseline in FPG at Week 24, adjusted for baseline value. (NCT00327015)
Timeframe: Baseline, Week 24

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy

Mean change from baseline in FPG at Week 24, adjusted for baseline value. (NCT00327015)
Timeframe: Baseline, Week 24

Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy

Mean change from baseline in A1C at Week 24, adjusted for baseline value. (NCT00327015)
Timeframe: Baseline, Week 24

Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy

Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjsuted for baseline value. (NCT00327015)
Timeframe: Baseline, Week 24

Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy

Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline value. (NCT00327015)
Timeframe: Baseline, Week 24

Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 104

Change from baseline at Week 104 is defined as Week 104 minus Week 0. (NCT00103857)
Timeframe: Week 104

Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 24

Change from baseline at Week 24 is defined as Week 24 minus Week 0. (NCT00103857)
Timeframe: Week 24

Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 54

Change from baseline at Week 54 is defined as Week 54 minus Week 0. (NCT00103857)
Timeframe: Week 54

Change From Baseline in FPG (Fasting Plasma Glucose) at Week 104

Change from baseline at Week 104 is defined as Week 104 minus Week 0. (NCT00103857)
Timeframe: Week 104

Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24

Change from baseline at Week 24 is defined as Week 24 minus Week 0. (NCT00103857)
Timeframe: Week 24

Change From Baseline in FPG (Fasting Plasma Glucose) at Week 54

Change from baseline at Week 54 is defined as Week 54 minus Week 0. (NCT00103857)
Timeframe: Week 54

Change From Baseline in HbA1c (Hemoglobin A1C) at Week 104

HbA1c is measured as a percent. This change from baseline reflects the Week 104 HbA1c percent minus the Week 0 HbA1c percent. (NCT00103857)
Timeframe: Week 104

Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24

HbA1c is measured as a percent. This change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent. (NCT00103857)
Timeframe: Week 24

Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54

HbA1c is measured as a percent. This change from baseline reflects the Week 54 HbA1c percent minus the Week 0 HbA1c percent. (NCT00103857)
Timeframe: Week 54

ACPRg

First phase response from the hyperglycemic clamp (NCT01779362)
Timeframe: 3-months after a medication washout

Insulin Sensitivity, M/I

Clamp measure of insulin sensitivity (NCT01779362)
Timeframe: 3-months after a medication washout

ß-cell Function Measured by Hyperglycemic Clamp Techniques at M12

Participants had 12-months of active therapy. Secondary results at the end of active intervention. (NCT01779362)
Timeframe: Secondary analysis was on all participants with a Month 12 visit.

ß-cell Response Measured by Hyperglycemic Clamp

Clamp measures of ß-cell response, co-primary outcomes (NCT01779362)
Timeframe: 3-months after medication washout (Month 15)

Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c)

Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group (previous oral antihyperglycemic medication [OAM] versus no previous OAM) as fixed effects and baseline HbA1c as a covariate. (NCT01126580)
Timeframe: Baseline, 26 weeks

Change From Baseline to 52-week Endpoint in Glycosylated Hemoglobin (HbA1c)

Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group (previous oral antihyperglycemic medication [OAM] versus no previous OAM) as fixed effects and baseline HbA1c as a covariate. (NCT01126580)
Timeframe: Baseline, 52 weeks

Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score, Change Version

The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score. (NCT01126580)
Timeframe: 52 weeks

Measurement of LY2189265 Drug Concentration for Pharmacokinetics: Area Under the Concentration Curve (AUC)

Evaluable pharmacokinetic concentrations from the 4-week, 13-week, 26-week, and 52-week timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state. (NCT01126580)
Timeframe: 4 weeks, 13 weeks, 26 weeks, and 52 weeks

Number of Participants With Adjudicated Pancreatitis at 52 Weeks Plus 30-day Follow up

The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 52 weeks plus 30-day follow up. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01126580)
Timeframe: Baseline through 52 weeks plus 30-day follow up

Number of Participants With Treatment Emergent Anti-LY2189265 Antibodies

A participant was considered to have treatment emergent LY2189265 anti-drug antibodies (ADA) if the participant had at least one titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement. The total number of treatment emergent ADA was not analyzed at 26 weeks. (NCT01126580)
Timeframe: Baseline through 52 weeks

Change From Baseline to 26 and 52 Weeks in Blood Pressure

Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline interval as a covariate, and participant as a random effect. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks

Change From Baseline to 26 and 52 Weeks in Body Mass Index (BMI)

Body mass index is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group as fixed effects and baseline BMI as a covariate. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks

Change From Baseline to 26 and 52 Weeks in Body Weight

Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group as fixed effects and baseline body weight as a covariate. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks

Change From Baseline to 26 and 52 Weeks in Daily Mean Blood Glucose Values From the 8-point Self-monitored Blood Glucose (SMBG) Profiles

The SMBG data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening; 2 hours post-evening meal; bedtime; and 3AM or 5 hours after bedtime. Least Squares (LS) means of the mean of the 8 time points (daily mean) were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group as fixed effects and baseline daily mean as a covariate. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks

Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval

The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline interval as a covariate, and participant as a random effect. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks

Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Heart Rate

Electrocardiogram (ECG) heart rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects and baseline interval as a covariate. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks

Change From Baseline to 26 and 52 Weeks in Fasting Blood Glucose

Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline fasting blood glucose as a covariate, and participant as a random effect. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks

Change From Baseline to 26 and 52 Weeks in Homeostasis Model Assessment of Beta-cell Function

The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-cell function. HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady-state beta cell function (%B) as a percentage of a normal reference population (normal young adults). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as percentages of a normal reference population (normal young adults). The normal reference populations were set at 100%. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline HOMA2 as a covariate, and participant as a random effect. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks

Change From Baseline to 26 and 52 Weeks in Pancreatic Enzymes

Amylase (total and pancreas-derived [PD]) and lipase concentrations were measured. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks

Change From Baseline to 26 and 52 Weeks in Pulse Rate

Sitting pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline interval as a covariate, and participant as a random effect. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks

Change From Baseline to 26 and 52 Weeks in Serum Calcitonin

(NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks

Change From Baseline to 26 and 52 Weeks in the Diabetes Symptoms Checklist Participant-reported Outcome (DSC-r) Score

"The Diabetes Symptoms Checklist-revised (DSC-r) was designed to assess the presence and perceived burden of diabetes-related symptoms. Respondents were to consider troublesomeness of 34 symptoms on a 5-point scale ranging from 5=extremely to 1=not at all. For symptoms/side-effects not experienced, the item was scored as 0. Symptoms were grouped into the following subscales: psychology-fatigue, psychology-cognitive, neurology-pain, neurology-sensory, cardiology, ophthalmology, hypoglycemia, and hyperglycemia. Subscale scores were calculated as the sum of the given subscale divided by the total number of items in the scale. Total score was computed from the sum of the 8 subscales and ranged from 0 to 40. Higher scores indicate greater symptom burden. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score." (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks

Change From Baseline to 26 and 52 Weeks in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score, Status Version

The Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) is used to assess participant treatment satisfaction at each study visit. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. Scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from 0 (very dissatisfied) to 36 (very satisfied). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks

Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Activities of Daily Living (IW-ADL) Score

"The Impact of Weight on Activities of Daily Living (renamed the Ability to Perform Physical Activities of Daily Living [APPADL]) questionnaire contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = not at all difficult and 1 = unable to do. The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score." (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks

Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Self-Perception (IW-SP) Score

The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks

Number of Participants With Adjudicated Cardiovascular Events at 52 Weeks Plus 30-day Follow up

Information on cardiovascular (CV) risk factors was collected at baseline. Data on any new CV event was prospectively collected using a CV event electronic case report form. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by an external committee of physicians with cardiology expertise. Nonfatal cardiovascular AEs to be adjudicated included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions, and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with CV events confirmed by adjudication is summarized cumulatively at 52 weeks plus 30-day follow up. Serious and all other non-serious adverse events regardless of causality are summarized in the Reported Adverse Events module. (NCT01126580)
Timeframe: Baseline through 52 weeks plus 30-day follow up

Number of Participants With Treatment Emergent Adverse Events at 26 and 52 Weeks

A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26 and 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01126580)
Timeframe: 26 weeks and 52 weeks

Number of Self-reported Hypoglycemic Events at 26 and 52 Weeks

Hypoglycemic events were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of less than or equal to 70 milligrams per deciliter [mg/dL]), or asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 70 mg/dL). A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01126580)
Timeframe: Baseline through 26 weeks and 52 weeks

Percent Change From Baseline to 26 and 52 Weeks in Total Cholesterol

Percent changes in total cholesterol were assessed using analysis of variance (ANOVA) on the rank-transformed data with only treatment included in the model. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks

Percentage Change From Baseline to 26 and 52 Weeks in High Density Lipoprotein Cholesterol (HDL-C)

Percentage changes in HDL-C were assessed using analysis of variance (ANOVA) on the rank-transformed data with only treatment included in the model. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks

Percentage Change From Baseline to 26 and 52 Weeks in Low Density Lipoprotein Cholesterol (LDL-C)

Percentage changes in LDL-C were assessed using analysis of variance (ANOVA) on the rank-transformed data with only treatment included in the model. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks

Percentage Change From Baseline to 26 and 52 Weeks in Triglycerides

Percentage changes in triglycerides were assessed using analysis of variance (ANOVA) on the rank-transformed data with only treatment included in the model. (NCT01126580)
Timeframe: Baseline, 26 weeks, and 52 weeks

Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) of Less Than 7% and Less Than or Equal to 6.5% at 26 and 52 Weeks

The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a logistic regression model with baseline, prior medication group, and treatment as factors included in the model. (NCT01126580)
Timeframe: 26 weeks and 52 weeks

Rate of Self-reported Hypoglycemic Events at 52 Weeks

Hypoglycemic events were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of less than or equal to 70 milligrams per deciliter [mg/dL]), or asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 70 mg/dL). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT01126580)
Timeframe: Baseline through 52 weeks

Reviews

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